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Job Details

Expert Statistician

Company: Edelway Switzerland AG
Location: Basel-City
Reference: Int 00004
Closing Date: 14 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Edelway AG is a professional services consultancy. From our Zürich headquarters, we provide pharma and business resources to our large multinational clients in Switzerland and throughout Europe.Our client pharmaceutical client based in Basel is looking for senior statistician to join them on a permanent basis.

Requirements:

The role:

Actively participate in and contribute to decision making related to clinical development strategies, regulatory and commercial strategies
Independently represent statistics function on global teams in support of clinical studies, indication level programs directly in full compliance with clients processes
Play a leadership role in the development and review of study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables
Study supporting clinical development objectives
Plan and direct compound level analysis and reporting activities (e.g. tables, listings, graphs) including work of other statisticians and programmers
Define vendor requirements and participate in the evaluation/selection of vendors. Manage activities of external vendors to ensure timeliness and quality of statistical outputs
Ensure review and approval of statistical deliverables
Identify and interact with external statistical experts for issues related to study design, methodology and results
Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program
Propose and implement solutions, escalate issues to management as appropriate in a timely manner
Contribute to the implementation of department standards and process improvements
Promote and use innovative statistical methodology in the design and analysis of clinical Lead evaluation and implementation of alternative analysis methodology and data presentation techniques
Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, implement innovative approaches at a compound level

Your profile:


PhD in statistics or bio statistics with minimum of 8 years of relevant pharmaceutical industry experience or MS in statistics or bio statistics with minimum of 10 years of relevant pharmaceutical industry experience
Track record in supervision and operational management of project teams (statistician and programmers) in full autonomy, with demonstrated leadership and excellent oral and written communications skills in English
Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics with experience of innovative design and/or analysis methodology implementation in clinical development
Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions, and experience with at least one NDA/CTDs or other global regulatory submissions
Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process
Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products)
Strong project management skills

Apply for this job: Expert Statistician

Contact Information:

Address:  Head Office
Sihleggstrasse 23 8832 Wollerau

Switzerland
Tel:  +41 58 717 7000
Website:  Visit Our Web Site

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